NCT01659268

Brief Summary

The purpose of this study is to compare if there difference in acquisition of knowledge and skills in airway management to baccalaureate nursing students submitted to different learning strategies: exhibition-dialogued class and practical activity in skill lab with low-fidelity mannequin or simulation class with low-fidelity mannequin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 2, 2014

Completed
Last Updated

June 2, 2014

Status Verified

December 1, 2012

Enrollment Period

3 months

First QC Date

August 2, 2012

Results QC Date

August 11, 2013

Last Update Submit

May 7, 2014

Conditions

Keywords

teachingpatient simulationlaryngeal masksbaccalaureate nursing educationteaching strategiessimulation

Outcome Measures

Primary Outcomes (2)

  • Scores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).

    Score obtained in pre and post-test written, time to obtain the first effective ventilation (chest expansion through adequate ventilation on the mannequin), number of attempts to insert the LMA in the simulation scenario (OSCE). Pre-test: 20 questions with score of 0.5 points each - minimum score=0 points and maximum score=10 points. Score 5-7 points was considered satisfactory; scores between 7-8 points was considered good performance; above 8 points excellent. Post-test: 20 questions with score of 0.5 points each - minimum score=0 points and maximum score=10 points. Score 5-7 points was considered satisfactory; scores between 7-8 points was considered good performance; above 8 points excellent. OSCE: instrument with total of 10 skills - each skill was subdivided in 4-5 activities (0.2-0.25 points each) - poor performance was score \< 5.0; satisfactory performance 5.0-7.0; good 7.0-8.5 and excellent above 8.5 points.

    Pretest: 40 minutes; Post-test: 40 minutes; OSCE: 10 minutes

  • Time to Conclusion of Simulation Scenario (OSCE)

    This result present the total time for execution of simulation scenario (OSCE) by the students.

    10 minutes

Secondary Outcomes (2)

  • Time for Acquisition of First Effective Ventilation, Adequate Tidal Volume and Stabilization of Patient.

    10 minutes (600 sec)

  • Number of Attempts to Insertion of LMA

    10 minutes (total time of scenario)

Study Arms (2)

Simulation class

EXPERIMENTAL

The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions. The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation.

Other: Simulation class

Exhibition-dialogued class

OTHER

Students will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, each subgroup composed of 4-5 students will go to the and practical activity in skill lab using the low-fidelity mannequin for 35 minutes.

Other: Exhibition-dialogued class

Interventions

The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions. The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation.

Simulation class

The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to practical activity in skill lab using the low-fidelity mannequin with duration of 35 minutes. Each subgroup will be composed of 5-6 students for the practice activity which will last 45 minutes.

Exhibition-dialogued class

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • student must be in the eighth period of course;
  • must be registered regular in the baccalaureate nursing course.

You may not qualify if:

  • absence in any step of study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Nursing at Ribeirao Preto - University of Sao Paulo

Ribeirão Preto, São Paulo, 14040-902, Brazil

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Limitations and Caveats

The limitations of this study are due to the small number of participants in the sample, even after running wide dissemination workshop for print and electronic media with students nursing institution involved in research.

Results Point of Contact

Title
Cesar Eduardo Pedersoli
Organization
College of Nursing at Ribeirão Preto, University of Sao Paulo

Study Officials

  • Cesar E Pedersoli, MSN

    College of Nursing at Ribeirao Preto - University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Performance of baccalaureate nursing students in insertion of supraglottic device (laryngeal mask): a randomized controlled trial in mannequins.

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 7, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 2, 2014

Results First Posted

June 2, 2014

Record last verified: 2012-12

Locations